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    Summary
    EudraCT Number:2006-005396-17
    Sponsor's Protocol Code Number:MRZ 60201-0617/1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-005396-17
    A.3Full title of the trial
    A prospective, randomized, double-blinded, international multicenter trial to investigate the efficacy and safety of NT 201 in comparison to placebo and to compare two different application schemes of NT 201 in the treatment of lateral periorbital wrinkles
    A.3.2Name or abbreviated title of the trial where available
    NT crow's feet
    A.4.1Sponsor's protocol code numberMRZ 60201-0617/1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xeomin
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXeomin
    D.3.2Product code NT 201
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNT 101
    D.3.9.3Other descriptive nameClostridium Botulinum Neurotoxin type A (150 kD) free of complexing proteins
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of lateral periorbital wrinkles ("Crow's feet")
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052611
    E.1.2Term Crow's feet
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to show superiority of NT 201 treatment over placebo for both application schemes and to provide evidence that both application schemes are equally effective in subjects with moderate to severe symmetrical lateral periorbital wrinkles in terms of response. Response is hereby defined as an improvement of at least 1 point for either eye area at week 4 compared to baseline according to the RNKLS assessed by an independent rater.

    A hierarchical testing procedure will be applied to show at the first level the superiority of the 3-injection regimen over placebo, at the second level superiority of the 4-injection regimen over placebo and at the third level equivalence of the two different NT 201 application schemes.
    E.2.2Secondary objectives of the trial
    Analysis and comparison of:
    - Treatment response rate compared to baseline for either eye area at week 2, week 12 and 20 according to RNKLS
    - Treatment response rate compared to baseline for either eye area at week 2, week 4, week 12 and week 20 according to RNKLS
    - Improvement of appearance of lateral periorbital wrinkles for either eye area compared to baseline at week 2, 4, 12 and 20 by the subject`s global assessment
    - Time to onset of treatment effect for either eye area assessed by the subject at week 2 and week 4 and fading for either eye area assessed by the subject at week 8 and week 12 between treatment groups and application schemes.
    As part of the safety evaluation during the trial the incidence of adverse events, hematology, clinical biochemistry and botulinum toxin antibody values, vital signs, physical examinations, concomitant medications and concomitant treatments will be investigated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Moderate (severity score of 2) to severe (severity score of 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to RNKLS
    - Symmetrical lateral periorbital wrinkles on both sides of the face at rest and at maximum smile
    - Man or woman between 18 and 60 years of age (inclusively)
    - Stable medical condition
    - Sum score of the evaluated questionnaire on quality of life, skin and cosmetics [FLQA-c] must be below the predefined cut-off value of 0
    - Willingness of the subject to participate as documented by written informed consent
    E.4Principal exclusion criteria
    - Significant facial asymmetry
    - Previous facial surgery, e.g. face-lifting
    - Wrinkles not caused by muscular contraction
    - Previous treatment with Botulinum toxin of any serotype within the last 6 months
    - Previous treatment with bio-degradable fillers in the periorbital area within the last 12 months
    - Any previous insertion of permanent material in the periorbital area (regardless of the time between previous treatment and this study)
    - Any facial cosmetic procedure (e.g., dermal filling, chemical peeling, photo rejuvenation) in the periorbital area within the last 12 months
    - Planned concomitant treatment with Botulinum toxin of any serotype in any body region during the study period
    - Any other planned facial aesthetic procedure during the study period
    - Inability to substantially reduce lateral periorbital wrinkles by physically spreading them apart
    - Any infection in the area of the injection sites
    - Any previous surgery or scars in the periorbital area
    - Any medical condition that may put the subject at increased risk by exposure to NT 201 or one of the ingredients of the formulation
    - Bleeding disorders
    - Regular intake of drugs with anticoagulative effect (e.g., warferin, heparin, cumarines, clopidogrel) within the last 10 days
    - Regular intake of vitamin E or calcium channel blockers within the last 10 days
    - Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function or that might interfere with the action of Botulinum toxin A
    - Diagnosis of Lambert Eaton syndrome/myasthenia gravis, amyotrophic lateral sclerosis or any other significant neuromuscular disease that might interfere with this study
    - Facial or skin conditions that in the opinion of the investigator could affect safety and/or efficacy results (e.g., acne, scars, psoriasis, allergic dermatitis, photodamage)
    - History of facial nerve palsy, ptosis, weakness of periorbital muscles etc.
    - Laxity of the lower lid
    - If in the opinion of the investigator the subject has unrealistic expectations
    - Pregnant woman, verified by a positive pregnancy test
    - Nursing woman or woman of childbearing potential without reliable means of contraception (reliable contraception defined as hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g. condom or diaphragm plus spermicidal cream) or woman planning pregnancy during the course of the trial
    - If in the opinion of the investigator the subject is unlikely to complete all study visits
    - Participation in a clinical study within 30 days prior to the screening visit
    - Previous randomization in this clinical study
    - Other contraindications which in the investigator’s opinion preclude participation in the study
    - Evidence of recent alcohol or drug abuse
    - Employees or direct relatives of an employee of the CRO, the Study Center or Merz Pharmaceuticals
    E.5 End points
    E.5.1Primary end point(s)
    The treatment response rate at week 4 (visit 4). A treatment response is defined as an improvement of at least 1 point on the RNKLS at week 4. (Improvement of 1 point on the RNKLS was previously considered to be clinically significant.)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-05-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 108
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-12
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